MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <6> SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337154001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bilirubin electrode lot number and expiration date were not provided.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 neonate patient sample tested for bilirubin on a cobas b 221 6 system.The result from the b221 system was 28.8 mg/dl.As this result was high, the customer re-centrifuged the sample and tested it on a cobas c311 instrument with a result of 15.91 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Qc was acceptable.Based on the database files for the instrument and calibration, there were no issues with the co-oximetry (coox) measurement path.It was noted that the cuvette was not replaced and no coox calibration was performed in apr-2025 or may-2025.Product labeling states: "perform a coox calibration each time you adjust the cuvette and at least once every 3 months." the specific root cause could not be determined; however, the investigation determined that the high bilirubin result was consistent with an overcompensation of the thb result due to preanalytical handling issues (the sample was not thoroughly mixed in the sample container before being aspirated into the capillary).Particles or clots in the sample can lead to an elevated thb value and, as this value is used as a correction factor for the bilirubin result, a higher result is produced.The investigation did not identify a product problem.

• Brand Name: COBAS B 221 <6> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22142169
• Report Number: 1823260-2025-01723
• Device Sequence Number: 8149581
• Product Code: CEM
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown